Table 2.

ORR, DOR in Confirmed Responders, Median PFS, and 6-Month PFS by mRECIST and RECIST v1.1 for All Patients and Those with TC3 or IC3 Expression

	Cohort 1		Cohort 2		Cohort 3
	mRECIST	RECIST v1.1	mRECIST	RECIST v1.1	mRECIST	RECIST v1.1
Response
ORR, % (95% CI), All	n = 31 32 (17–51)	n = 31 29 (14–48)	n = 92 21 (13–30)	n = 92 19 (11–28)	n = 13 23 (5–54)	n = 13 23 (5–54)
ORR, % (95% CI), TC3 or IC3	n = 7 43 (10–82)	n = 7 43 (10–82)	n = 38 32 (18–49)	n = 38 26 (13–43)	n = 8 25 (3–65)	n = 8 25 (3–65)
Median DOR, months (range), All	n = 10 11.5 (2.3–30.4+)	n = 9 9.2 (2.3–30.4+)	n = 19 17.0 (5.6+–44.2+)	n = 17 17.0 (2.8–44.2+)	n = 3 NE (5.6+–9.9+)	n = 3 NE (2.8–9.9+)
Median DOR, months (range), TC3 or IC3	n = 3 19.8 (2.9–30.4+)	n = 3 8.7 (2.9–30.4+)	n = 12 29.0 (5.6+–44.2+)	n = 10 29.0 (2.8–44.2+)	n = 2 NE (5.6+–9.9+)	n = 2 NE (5.6+–9.9+)
PFS
Median PFS, months (range), All	n = 31 5.5 (0.9–37.9+)	n = 31 4.5 (0.9–37.9+)	n = 93 3.7 (0.0+–45.5+)	n = 93 2.7 (0.0+–45.5+)	n = 13 4.3 (1.1–16.2)	n = 13 2.5 (1.0–11.3+)
Median PFS, months (range), TC3 or IC3	n = 7 5.4 (3.3–34.3+)	n = 7 5.4 (3.3–34.3+)	n = 38 7.7 (0.0+–45.5+)	n = 38 4.1 (0.0+–45.5+)	n = 8 5.6 (1.4–16.2)	n = 8 2.3 (1.1–11.3+)
PFS rates
12-month PFS, % (95% CI), All	n = 31 31 (14–48)	n = 31 20 (6–34)	n = 93 29 (19–39)	n = 93 23 (14–32)	n = 13 24 (0–50)	n = 13 NE
12-month PFS, % (95% CI), TC3 or IC3	n = 7 29 (0–62)	n = 7 14 (0–40)	n = 38 41 (24–57)	n = 38 33 (18–49)	n = 8 38 (4–71)	n = 8 NE
30-month PFS, % (95% CI), All	n = 31 12 (0–25)	n = 31 13 (0–25)	n = 93 10 (3–17)	n = 93 10 (4–17)	n = 13 NE	n = 13 NE
30-month PFS, % (95% CI), TC3 or IC3	n = 7 14 (0–40)	n = 7 14 (0–40)	n = 38 20 (6–35)	n = 38 20 (6–34)	n = 8 NE	n = 8 NE

CI, confidence interval; IC, immune cell; DOR, duration of response; ORR, objective response rate; PFS, progression-free survival; mRECIST, modified Response Evaluation Criteria in Solid Tumors; TC, tumor cell; NE, not estimable; + denotes a censored value.